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Recall Observatory FDA recall evidence

Core noun

Failure mode assignments

Deterministic labels derived from preserved recall-reason text.

Indexed record set

89,789 assignments

Page 8 of 3592

Mode Product Rule Evidence excerpt
Device software or design Agfa HealthCare Enterprise Imaging XERO Viewer reason.device_software_design · v1.0.0 software defect
Device software or design Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software reason.device_software_design · v1.0.0 Software issue
Device software or design VELYS Robotic-Assisted Solution Base Product No.: 451570100 reason.device_software_design · v1.0.0 software v1.5.1 has a system software issue
Device software or design DigitalDiagnost 4 High Performance. radiography and fluoroscopy system reason.device_software_design · v1.0.0 issue in the firmware
Device software or design ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 reason.device_software_design · v1.0.0 software issues with ARTIS pheno systems with software version VE10B. This may
Device software or design Zenition 50, Model #718096 reason.device_software_design · v1.0.0 firmware issue
Device software or design STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 reason.device_software_design · v1.0.0 bug in this firmware
Device software or design STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 reason.device_software_design · v1.0.0 bug in this firmware
Device software or design Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology. reason.device_software_design · v1.0.0 Software error
Device software or design BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment. reason.device_software_design · v1.0.0 firmware may
Device software or design Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss. reason.device_software_design · v1.0.0 Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can
Device software or design Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss. reason.device_software_design · v1.0.0 Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can
Device software or design Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss. reason.device_software_design · v1.0.0 Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can
Device software or design NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 reason.device_software_design · v1.0.0 Software anomaly
Device software or design Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US reason.device_software_design · v1.0.0 software to help reduce the incidence of Error
Device software or design Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0 reason.device_software_design · v1.0.0 Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may
Device software or design The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample. reason.device_software_design · v1.0.0 software versions 2.59.3 and all earlier versions, which can
Device software or design Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 reason.device_software_design · v1.0.0 software has a defect that leads to an issue where incorrect
Device software or design Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10 reason.device_software_design · v1.0.0 firmware and the Automation software without any error
Device software or design Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032 reason.device_software_design · v1.0.0 software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error
Device software or design Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 reason.device_software_design · v1.0.0 software calculation threshold is reached. The outflow measurement will
Device software or design Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. reason.device_software_design · v1.0.0 issue (bug) has been identified with the interface and image software
Device software or design Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815 reason.device_software_design · v1.0.0 Software error, the software can produce an incorrect
Device software or design Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 reason.device_software_design · v1.0.0 software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue
Device software or design Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752 reason.device_software_design · v1.0.0 cybersecurity vulnerability

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